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Recruiting NCT05807178

Stabilization of Circadian Rhythms in Delirious ICU Patients Through Light Intervention

No phase Interventional Circadian Dysrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dynamic Light Therapy Device, LSA-1, Dynamic Light Therapy Device, LSA-2.
Who it may be relevant to
Registry conditions: Circadian Dysrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The investigators will examine the effects of dynamic light therapy on circadian rhythms in delirious intensive care unit (ICU) patients. In a randomized controlled trial (RCT), they will investigate the effects of a specific light algorithm on rhythms of serum melatonin, clock gene expression, the proteome, and metabolome, compared to standard hospital lighting, supported by the data science algorithms to improve vital-based algorithms with light interventions.

Interventions

  • Device Dynamic Light Therapy Device, LSA-1
    Dynamic Light Therapy
  • Device Dynamic Light Therapy Device, LSA-2
    Light Exposition

Primary outcome measures

  • Rhythmicity of melatonin concentration [Time frame: Plasma melatonin levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion]
Secondary outcome measures (12)
  • Clock genes [Time frame: Clock gene expression levels will be assessed for every 4 hours on day 1 and day 5 after study inclusion.]
  • Metabolomics [Time frame: Metabolomic measurements be assessed up to 3 (6-9) months.]
  • Proteomics [Time frame: Proteomic measurements will be assessed up to 3 (6-9) months.]
  • Inflammation parameters [Time frame: Inflammation parameter levels will be assessed up to 3 (6-9) months.]
  • Incidence of intensive care unit delirium [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Delirium-free days in the intensive care unit [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Delirium Severity [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Depth of Sedation [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Level of analgesia 1 [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Level of analgesia 2 [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Level of analgesia 3 [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]
  • Level of analgesia 4 [Time frame: Participants will be followed up until discharge from the intensive care unit (maximum up to day 5)]

Eligibility criteria

Inclusion criteria

  • Patient capable of giving consent or additionally existing legal caregiver or authorized/spouse representative in case of non-consenting patients in the intensive care unit
  • Male and female patients with age ≥ 18 years
  • Expected intensive care unit stay ≥ 2 days
  • Positive delirium during and up to a maximum of 30 days after study inclusion (determined by CAM-ICU, at least once per shift)

Exclusion criteria

  • Participation in other clinical studies during the study period and ten days before
  • Previous ICU treatment during the current hospital stay
  • Patients with psychiatric diseases
  • Patients with a history of stroke and known severe residual cognitive deficits
  • Patients with a history of cardiopulmonary arrest or pulseless electric activity with cardiopulmonary resuscitation followed by therapeutic hypothermia during entire hospital stay
  • Amaurosis
  • History of sleep-related breathing disorders
  • History or suspicion of hypoxic brain damage
  • History or suspicion of elevated intracranial pressure in the last 7 days before study inclusion
  • Patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
  • The informed consent of the patient or the subject's legally acceptable representative can't be obtained in time
  • History of photoallergic reactions or history of visually triggered seizures
  • Severe eye diseases (e.g. retinopathy, glaucoma) or high sensitivity to bright light
  • Patients with liver cirrhosis
  • Patients with a probability of survival <24h
  • Optic neuritis within the last 3 months
  • Travel across two time zones within 3 months prior to study screening
  • Women who are pregnant, have a positive pregnancy test, are breastfeeding or plan to become pregnant during the course of this clinical trial
  • Therapy-refractory blood coagulation disorder and inability to consent are exclusion criteria for a muscle biopsy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 2 centers
  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Charité Mitte — Berlin
  • Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Campus Virchow Kliniku — Berlin

Identifiers

NCT: NCT05807178 · CIRCA-MED-WP2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗